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EU’s Eudamed Database: Crucial To New Regs, But Will It Be Ready in Time?

The EU must have its new Eudamed database operating smoothly to support the implementation of the new IVD and Medical Device Regulations. But experience with its predecessor suggests progress may not always be straightforward.

Europe Policy and Regulation Diagnostics

Digital Health – The Next Gold Rush Of Opportunities, Says Kaiser Permanente Ventures

Digital health is no longer a buzzword but a reality, with venture capital investment in this space reaching an all-time high. This Q&A with Jordan Kramer of Kaiser Permanente Ventures provides insight into why digital health investment has rocketed, how Kaiser Permanente's approach to investing in this sector, and where the opportunities and challenges lie for digital health start-ups.

Financing StartUps and SMEs Strategy

Electronic Labeling Submissions Proposed For Home-Use Devices

US FDA is proposing a rule that would require manufacturers to electronically submit labeling and package inserts for class II and III devices that are intended for use outside health-care facilities. The agency is also planning a public database of the labeling.

Regulation Medical Device Pre Market Regulation

Device Week – October 17, 2016

On this week's podcast, we discussed trends and challenges with adverse-event reporting in the US, lab-developed test marketing, some companion diagnostic data and a look ahead to this week's AdvaMed conference in Minneapolis.

Medical Device In Vitro Diagnostics Policy and Regulation

Recent Tweets from Medtech Insight

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French Medtechs Demand Attention To Ongoing Reimbursement Delays

French medtech manufacturers are expecting positive results from recent ministerial efforts to make the national health-care products reimbursement agency, the CEPS, speed up its current slow handling of applications for products and services to enter commercial use in France's public-health system.

France Market Access Reimbursement

Next Step In Global Convergence: FDA Looks To Make IMDRF Software Guidance Its Own

The US agency issued a draft guidance on clinical evaluation considerations for "software as a medical device." But FDA did not write the guidance internally. Instead it is an International Medical Device Regulators Forum document that was put together collaboratively by regulatory officials from across the globe. This is the first time FDA is attempting to wholesale adopt an IMDRF guidance document as its own.

Policy and Regulation Regulation Medical Device

Latest From Policy and Regulation

EU Regs: Resource Gaps Could Threaten Existing Products, But Some Protections In Place

There is still a lack of clarity over whether notified bodies and competent authorities will find sufficient resources for the smooth implementation of the forthcoming Medical Devices and IVD Regulations. Does this mean some products considered safe today may have to be removed unnecessarily from the EU market?

Europe Medical Devices

FDA Formally Classifies Cardiac Surgery Device, Robotic Arm

Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.

Policy and Regulation Pre Market Regulation

New Industry Survey Recruits Device Firms For Study On Complaints, Failure Management

The confidential device industry survey can aid firms as they look to gain new insights into how competitors handle product complaints and failures, according to organizers of the study.

Policy and Regulation Quality Control

Warning Letter Roundup & Recap – Oct. 19

No device-related warning letters were released by US FDA the week of Oct. 19.

Device Warning Letters Policy and Regulation

UK Diagnostic Fret Over Loss of Support In Evidence Centers Restructure

Changes are afoot for the four UK Diagnostic Evidence Co-operatives that help generate clinical and cost-effectiveness data for innovative IVDs. Companies worry it could mean diagnostic industry needs get lost among broad medtech targets. Also, a roundup of the British In Vitro Diagnostics Association's key priorities, including the EU IVD Regulation, procurement issues, antimicrobial resistance, and of course, Brexit, highlighted at the group's 2016 annual meeting.

United Kingdom In Vitro Diagnostics

Industry: Next-Gen Sequencing Draft Guidances Have Good Ideas But Need Tweaks

The 37 groups and individuals who submitted comments on FDA’s two draft guidances on next-generation sequencing issued in July expressed appreciation for the thinking behind the guidances, but found bones to pick with some details.

Regulatory Pre Market Regulation

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Brexit Will Drive UK And China Closer Together

The UK's decision to quit the European Union will further increase the country's need to find support from China, one of the UK's most important non-EU partners for trade and investment. Medtech companies could take advantage of opportunities from the two countries' strengthening ties.

United Kingdom China Strategy

Latest From Commercial

Cybersecurity Allegations, Safety Alert Will Not Impact St. Jude Acquisition, Abbott Affirms

Abbott Labs' CEO Miles White expressed strong confidence in St. Jude and an unimpeded acquisition of the firm in the wake of continued cybersecurity allegations and a device-safety advisory.

Medical Device Commercial

No Surprise As Abbott Cuts Loose Angio-Seal, Femoseal To Terumo

Abbott and St. Jude Medical are to lighten their cardiovascular portfolios – and hopefully facilitate the completion of Abbott's pending $25bn acquisition of St. Jude – by selling three product lines to Terumo. Two of the three product lines to be divested come as little surprise, but one product was acquired by Abbott only earlier this year.

M and A Cardiology

Oxford Immunotec Bulks Up Immunology Dx Offering

Oxford Immunotec, an immunology-focused diagnostics company, has acquired US company Immunetics.

In Vitro Diagnostics M and A

Ocular And UroGen Team-Up With Drug-Makers On Drug-Delivery Hydrogels

Ocular Therapeutix will work with Regeneron to create a sustained-release formulation of aflibercept for the treatment of wet age-related macular degeneration and other serious retinal diseases. On the same day, UroGen announced plans to work with Allergan on a hydrogel for controlled release delivery of drugs to the bladder.

Ophthalmology Innovation

Siemens Makes PHM Debut With Partner IBM; Verily, 3M Also Link Arms

Siemens Healthineers will be offering population health management solutions for the first time, as it teams up with IBM Watson Health. Verily and 3M are also joining the PHM partnering wave.

Commercial Healthcare Systems

How J&J Hopes To Disrupt India's Diabetes Care Paradigm

Sushobhan Dasgupta, managing director of Johnson & Johnson Medical India, discusses how J&J's new go-to-market strategies are playing out, the role of e-commerce for medical devices in India, and how the company is leveraging its capabilities to provide solutions for the whole diabetic care pathway.

India Diabetic Care

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Mass Spectrometry Makes Inroads Into The Clinical Lab

The use of mass spectrometry in IVD applications looks to be gaining momentum. In this article, Alina Kim, Sunayana Karra and Akash Kundu of Boston Biomedical Consultants report on new developments and innovations showcased at the American Association for Clinical Chemistry Annual (AACC) & Clinical Lab Expo (CLE) annual meeting that took place this summer. Players at the convention exhibited a range of Class I medical devices, research use only liquid chromatography tandem mass spectrometry (LC-MS/MS), matrix-assisted laser desorption/ionization (MALDI-TOF), inductively coupled plasma mass spectrometry (ICP-MS), sample preparation automation platforms, and software solutions.

In Vitro Diagnostics Cancer Innovation

Latest From Research and Development

electroCore Stimulates More Promise With Migraine Therapy

New research published in the Journal of Headache and Pain has demonstrated the potential of electroCore's noninvasive vagal nerve stimulation therapy for reducing menstrual migraine attacks by more than a third.

Neurology Clinical Trials

Liquid Biopsy, Particle-Beam Radiotherapy Get 'Moonshot' Commitments

The White House announced 36 new project commitments under its ongoing Cancer Moonshot oncology initiative, including an ambitious project to create an open liquid-biopsy database and a NASA-NCI collaboration to explore the benefits of particle-beam radiotherapy.

Innovation Research and Development

Myriad's Ovarian Cancer Test Proves Its Mettle as Tesaro Companion Dx

Myriad’s myChoice HRD test has demonstrated its ability to identify more than twice as many ovarian cancer patients who may benefit from treatment with Tesaro’s drug investigational drug niraparib, compared with patient stratification by germline-BRCA testing alone.

Clinical Trials Research and Development

Inivata Launches Major US Study To Back Liquid Biopsy Tech In Lung Cancer

Cambridge University spin-out Inivata has launched a major US clinical validation study to evaluate its liquid biopsy approach against tissue-based diagnostic methods in non-small cell lung cancer patients.

Cancer In Vitro Diagnostics

Mercator Moves To New Studies Following DANCE Success

Results of DANCE, the first large-scale trial of Mercator’s Bullfrog micro-infusion catheter device, showed local dexamethasone-delivery with Bullfrog yields patient outcomes that compare favorably to that of drug-coated balloons in patients with peripheral artery disease. The company is pursuing more trials of Bullfrog in peripheral artery disease patients even though the device already has a CE mark and 510(k) clearance.

Clinical Trials Research and Development

OUS Approvals Analysis: BSX, Edwards Score New CE Marks In TAVR Battlefield; Chinese DES Advances In Asia

September's list of devices approved outside the US include a new transcatheter aortic valve in Europe, two orthopedic devices and a gynecology device in Australia, and a drug-eluting stent in Pakistan.

Research and Development Approvals